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A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines

6. april 2015 opdateret af: US Department of Veterans Affairs
Schizophrenia, a chronic psychiatric disorder, is the second most frequent VA discharge diagnosis. Medication management practices for schizophrenia often are not guideline-concordant and place patients at risk for adverse outcomes. This project tests a new strategy to standard implementation for VHA Schizophrenia Guidelines.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Background:

Schizophrenia, a chronic psychiatric disorder, is the second most frequent VA discharge diagnosis. Medication management practices for schizophrenia often are not guideline-concordant and place patients at risk for adverse outcomes. This project tests a new strategy to standard implementation for VHA Schizophrenia Guidelines.

Objectives:

Research objectives are: (1) to compare the effectiveness of a conceptually-based, enhanced intervention to that of a basic educational strategy with regard to improving guideline adherence and patient compliance; (2) to compare the effectiveness of the two strategies with regard to improving symptom and side effect outcomes; (3) to determine the effect of the enhanced intervention on service utilization for acute exacerbations of schizophrenia; (4) to determine the extent to which guideline-concordant medication management improves patient outcomes; and (5) to examine providers' knowledge of and attitudes toward guidelines.

Methods:

Thirteen VA sites were considered for the study, and VistA data were extracted to assess baseline guideline performance. Seven sites were selected and received basic education about schizophrenia guidelines. Three of these sites were randomly selected to receive the enhanced intervention, employing a nurse coordinator to promote providers' guideline adherence and patients' treatment adherence. Subjects with an acute exacerbation of schizophrenia were enrolled and were interviewed at baseline and six months using the Positive and Negative Syndrome Scale, the Schizophrenia Outcomes Module, and the Barnes Akathisia Scale. Data on guideline adherence were collected from medical records and VistA files. When data collection is completed, analyses will be conducted to determine the effectiveness of the enhanced intervention with regard to improving guideline adherence and patient outcomes.

Status:

The project is ongoing. To date, 401 subjects have been enrolled in the intervention study. The rate of completed follow-up assessments to date is 86 percent.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

400

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20422
        • Washington DC VA Medical Center, Washington, DC
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Southeast Louisiana Veterans Health Care System, New Orleans, LA
    • Maryland
      • Tuscaloosa, Maryland, Forenede Stater, 35404
        • Tuscaloosa VA Medical Center, Tuscaloosa, AL
    • Texas
      • Dallas, Texas, Forenede Stater, 75216
        • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
      • Houston, Texas, Forenede Stater, 77030
        • Michael E. DeBakey VA Medical Center, Houston, TX
      • San Antonio, Texas, Forenede Stater, 78229
        • South Texas Health Care System, San Antonio, TX

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

1. Subjects must have a diagnosis of schizophrenia. 2. Subjects must have been admitted to an inpatient psychiatry unit or seen in an ambulatory care clinic or the Emergency Room at a study site for symptoms of acute exacerbation. 3. Must be able to provide informed consent themselves or informed consent by a guardian.

Exclusion Criteria:

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Arm 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Richard R. Owen, MD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studieafslutning (Faktiske)

1. september 2000

Datoer for studieregistrering

Først indsendt

14. marts 2001

Først indsendt, der opfyldte QC-kriterier

15. marts 2001

Først opslået (Skøn)

16. marts 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. april 2015

Sidst verificeret

1. februar 2007

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CPG 97-027

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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